Novo Nordisk gets EU approval for Refixia®

Wednesday, Jun 07, 2017

Novo Nordisk announced that the European Commission has granted marketing authorisation for Refixia® for the treatment of adolescents and adults with haemophilia B. The authorisation covers all 28 European Union member states.

Refixia® is the brand name for nonacog beta pegol; N9-GP. Refixia® is indicated for prophylaxis, on-demand treatment of bleeding and surgical procedures in adolescent (>12 years of age) and adult patients with haemophilia B (congenital factor IX deficiency). The efficacy and safety evaluation was based on 115 patients across the five paradigm clinical trials, and the marketing authorisation follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), provided 24 March 2017.

"We are excited about the approval of Refixia® in the EU, and we consider it an important expansion of the treatment options for patients with haemophilia B," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "The strong clinical profile of Refixia® provides haemophilia B patients with better protection against bleeds, even into damaged joints, and an overall improved quality of life."

Novo Nordisk expects to launch Refixia® in the first European countries in the fourth quarter of 2017.